AnesthesiaNCT06074471
Motor Sparing Supraclavicular Block
A study testing ultrasound guided supraclavicular brachial plexus block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, Regional Anesthesia Morbidity
- What is being tested?
- ultrasound guided supraclavicular brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for upper limb surgeries under supraclavicular brachial plexus block
- American Society of Anesthesiologists (ASA) status I and III
- between ages of 18 and 60 years
Who cannot join
- Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3
- infection at the injection site
- Allergy to local anesthetics
- Severe cardiopulmonary disease (≥ASA IV)
- Diabetic or other neuropathies
- Motor disorders
- Patients receiving opioids for chronic analgesic therapy
- Inability to comprehend visual analogue scale (VAS).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university Hospitals. kasralainy
Cairo, Governorate, 002
Nagy malak, 01552480258, nagymalak789@yahoo.com
About this study
Official title: Motor Sparing Supraclavicular Brachial Plexus Block (MS-SCBPB): A Randomized Controlled Trial
This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects.
Read the detailed description
On arrival of the patients to regional anesthesia room, patients will be secured with 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
Before receiving supraclavicular brachial plexus block, patients will be randomly assigned into one of the two study groups:
MS-SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.20% and 8 mg dexamethasone.
SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.5% and 8 mg dexamethasone.
Another doctor not involved in the block procedure will evaluate the patients postoperative.
Technique of SCBPB:
The technique of ultrasound-guided supraclavicular brachial plexus block will be performed with the patient in semi-sitting position with head tilted to the opposite side of injection site. A linear ultrasound probe (4-12MHz) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane under direct vision aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, a total of 10 mL of drug will be injected, aspirating every 5 ml. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial brachial plexus after negative aspiration, 10 mL of drug will be injected, aspirating every 5 ml.
Block assessment:
Time needed for surgical block: the time interval from the end of ultrasound guided supraclavicular brachial plexus block injection till achievement surgical anesthesia
Assessment of surgical anesthesia using a 3-point score:
Extent of sensory block:
In all four nerves: hypothenar eminence (ulnar nerve), thenar eminence (median nerve), dorsum of hand (radial nerve), and lateral aspect of the forearm (musculocutaneous nerve) 0 = loss of sensation to light touch, 1 = loss of sensation to pinprick, 2 = normal sensation
Extent of motor block:
In all four nerves: thumb adduction (ulnar nerve), thumb opposition (median nerve), thumb abduction (radial nerve), and flexion of the elbow in supination and pronation (musculocutaneous nerve) 0 = no movement, 1 = paresis, 2 = normal movement Interpretation : Block success for surgical anesthesia is defined as the achievement of sensory and or motor scores of 1 or less at 5, 10, 15, 20, and 30 minutes post-injection.
Intraoperative Care:
An anesthesiologist blinded to group allocation will be attending for monitored anesthesia care with a safe conscious sedation intraoperatively, titrated to patient comfort using low intravenous doses of midazolam (1-3mg), fentanyl (1-2 μg/kg), and/or Propofol (25-75 μg/kg/min). In the event of failed block, it will be managed with either local anesthetic supplementation at the corresponding spared nerve or converted to general anesthesia.
Postoperatively, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. Intravenous morphine titration will be carried out at patient wake-up to achieve pain control (Using visual analogue scale (VAS) for pain assessment from 0 the Best to 10 the worst) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score of ≥ 4 and patients who will request rescue analgesia will be treated with IV morphine in 2 mg increments every 4 hours with upper limit for the total administered dose (maximum 20 mg per day). If the patient appeared sedated (Ramsay sedation scale > 2), and/or severe morphine-related side effects are encountered including respiratory depression (Spo2 < 95% and/or RR < 12 breaths/min), allergic reaction, hypotension, or severe pruritus, morphine titration will be stopped and the patient will be excluded from the study.
- Conditions
- Anesthesia, Regional Anesthesia Morbidity
- Being tested
- ultrasound guided supraclavicular brachial plexus block
- Keywords
- Motor sparing, SCBP block, Upper limb operations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided supraclavicular brachial plexus blockProcedure or surgery
Also called Drugs used (bupivacaine and dexamethazone)
Block will be performed in semi-sitting position with head tilted to the opposite side of injection site. linear probe (4-12MHz) (Mindray Digital Ultrasonic Model DP-10 "SN 6N-49005130" 2014-09. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.LTD) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, 10 mL of drug will be injected. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial plexus after negative aspiration another 10 ml will be injected, total drug injected 20 ml (18 mL of drug will be injected with addition to 8mg dexamethasone (2ml))
| Study group | Role | What they receive |
|---|---|---|
| MS-SCBPB Group (n=22) | Experimental | receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.20%) "9 ml Bupivacaine+9ml lignocaine +2ml Dexamethasone 8mg " Receives: Procedure: ultrasound guided supraclavicular brachial plexus block |
| SCBPB Group (n=22): | Active comparator | receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.5%) "18 ml Bupivacaine+2ml Dexamethasone 8mg" Receives: Procedure: ultrasound guided supraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of motor blockade
Duration of motor blockade
Measured: 24 hours
Secondary outcomes (5)
Time needed for surgical block:
the time interval between the injection of the study medication till surgical anesthesia.
Measured: 24 hours
Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Measured: 24 hours
Time to first analgesic request
Time to first analgesic request Using Visual analogue scale (VAS) for pain assessment from 0 the Best to 10 the worst) ...rescue analgesic given if VAS >4
Measured: 24 hours
Visual analogue scale (VAS)
Visual analogue pain score for pain assessment from 0 the Best to 10 the worst) at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Measured: 24 hours
Total morphine requirements
Total morphine requirements 24 hours postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Sep 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drugs used (bupivacaine-lidocaine-Dexamethazone) Rescue analgesic is morphine
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074471
- Sponsor's protocol ID
- N-267-2023
- Status last verified
- May 2024
- First submitted
- 25 Sep 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Sparing Supraclavicular Brachial Plexus Block (MS-SCBPB): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06074471
- Acronym / sponsor ID
- N-267-2023
- Conditions
- Anesthesia, Regional Anesthesia Morbidity
- Keywords
- Motor sparing, SCBP block, Upper limb operations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects.
Detailed description
On arrival of the patients to regional anesthesia room, patients will be secured with 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
Before receiving supraclavicular brachial plexus block, patients will be randomly assigned into one of the two study groups:
MS-SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.20% and 8 mg dexamethasone.
SCBPB Group (n=22): this group will receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine 0.5% and 8 mg dexamethasone.
Another doctor not involved in the block procedure will evaluate the patients postoperative.
Technique of SCBPB:
The technique of ultrasound-guided supraclavicular brachial plexus block will be performed with the patient in semi-sitting position with head tilted to the opposite side of injection site. A linear ultrasound probe (4-12MHz) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane under direct vision aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, a total of 10 mL of drug will be injected, aspirating every 5 ml. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial brachial plexus after negative aspiration, 10 mL of drug will be injected, aspirating every 5 ml.
Block assessment:
Time needed for surgical block: the time interval from the end of ultrasound guided supraclavicular brachial plexus block injection till achievement surgical anesthesia
Assessment of surgical anesthesia using a 3-point score:
Extent of sensory block:
In all four nerves: hypothenar eminence (ulnar nerve), thenar eminence (median nerve), dorsum of hand (radial nerve), and lateral aspect of the forearm (musculocutaneous nerve) 0 = loss of sensation to light touch, 1 = loss of sensation to pinprick, 2 = normal sensation
Extent of motor block:
In all four nerves: thumb adduction (ulnar nerve), thumb opposition (median nerve), thumb abduction (radial nerve), and flexion of the elbow in supination and pronation (musculocutaneous nerve) 0 = no movement, 1 = paresis, 2 = normal movement Interpretation : Block success for surgical anesthesia is defined as the achievement of sensory and or motor scores of 1 or less at 5, 10, 15, 20, and 30 minutes post-injection.
Intraoperative Care:
An anesthesiologist blinded to group allocation will be attending for monitored anesthesia care with a safe conscious sedation intraoperatively, titrated to patient comfort using low intravenous doses of midazolam (1-3mg), fentanyl (1-2 μg/kg), and/or Propofol (25-75 μg/kg/min). In the event of failed block, it will be managed with either local anesthetic supplementation at the corresponding spared nerve or converted to general anesthesia.
Postoperatively, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. Intravenous morphine titration will be carried out at patient wake-up to achieve pain control (Using visual analogue scale (VAS) for pain assessment from 0 the Best to 10 the worst) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score of ≥ 4 and patients who will request rescue analgesia will be treated with IV morphine in 2 mg increments every 4 hours with upper limit for the total administered dose (maximum 20 mg per day). If the patient appeared sedated (Ramsay sedation scale > 2), and/or severe morphine-related side effects are encountered including respiratory depression (Spo2 < 95% and/or RR < 12 breaths/min), allergic reaction, hypotension, or severe pruritus, morphine titration will be stopped and the patient will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Drugs used (bupivacaine-lidocaine-Dexamethazone) Rescue analgesic is morphine
| Arm | Type | Receives |
|---|---|---|
| MS-SCBPB Group (n=22) | Experimental | Procedure: ultrasound guided supraclavicular brachial plexus blockreceive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.20%) "9 ml Bupivacaine+9ml lignocaine +2ml Dexamethasone 8mg " |
| SCBPB Group (n=22): | Active comparator | Procedure: ultrasound guided supraclavicular brachial plexus blockreceive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.5%) "18 ml Bupivacaine+2ml Dexamethasone 8mg" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for upper limb surgeries under supraclavicular brachial plexus block
- American Society of Anesthesiologists (ASA) status I and III
- between ages of 18 and 60 years
Key exclusion criteria (8 listed)
- Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3
- infection at the injection site
- Allergy to local anesthetics
- Severe cardiopulmonary disease (≥ASA IV)
- Diabetic or other neuropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided supraclavicular brachial plexus blockAlso: Drugs used (bupivacaine and dexamethazone)Block will be performed in semi-sitting position with head tilted to the opposite side of injection site. linear probe (4-12MHz) (Mindray Digital Ultrasonic Model DP-10 "SN 6N-49005130" 2014-09. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.LTD) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, 10 mL of drug will be injected. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial plexus after negative aspiration another 10 ml will be injected, total drug injected 20 ml (18 mL of drug will be injected with addition to 8mg dexamethasone (2ml)) | Procedure or surgery | MS-SCBPB Group (n=22), SCBPB Group (n=22): |
Primary outcome
Duration of motor blockade
Time frame: 24 hours
Duration of motor blockade
5 secondary outcomes
Time needed for surgical block:
Time frame: 24 hours
Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Time frame: 24 hours
Time to first analgesic request
Time frame: 24 hours
Visual analogue scale (VAS)
Time frame: 24 hours
Total morphine requirements
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided supraclavicular brachial plexus block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagy malak, MD (01552480258, nagymalak@kasralainy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of motor blockade (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.